職位描述
ComplianceAssociateManger質(zhì)量監(jiān)督副經(jīng)理
YourResponsibilities:
Yourresponsibilitiesinclude,butnotlimitedto:
MaintainQualification/ValidationSystemofBNP.MonitorthestatusofQualification/Validationandensureequipment/utilityandcontrolinstrumentforGMPactivitiesarevalidated/qualified.ReviewandchecktheQualification/Validationdocumentationforcorrectness,completenessaccordingtobothtechnicalandGMPspecificrequirement.
維護(hù)工廠確認(rèn)/驗(yàn)證系統(tǒng)。監(jiān)測其確認(rèn)/驗(yàn)證狀態(tài)以確保設(shè)備/設(shè)施和相應(yīng)儀器儀表符合GMP要求。復(fù)核并檢查確認(rèn)/驗(yàn)證文件的正確性，確保從技術(shù)層面和GMP完全符合指定要求。
Assuranceoflocalconcept/guidelinesforproductrelatedprocessvalidationandconfirmation,cleaningvalidation,transportationvalidation,deviation/investigationduringprocessvalidation/confirmation,cleaningvalidationandtransportationvalidationarealignedwithregulatoryrequirementandNovartisrequirements.
確保產(chǎn)品相關(guān)的工藝驗(yàn)證和確認(rèn)，清潔驗(yàn)證，運(yùn)輸驗(yàn)證相關(guān)的觀念及指導(dǎo)，工藝驗(yàn)證/確認(rèn)，清潔驗(yàn)證及運(yùn)輸驗(yàn)證相關(guān)的偏差/調(diào)查符合法規(guī)要求及諾華要求.
Participateinestablishment,implementationandmaintenanceofthequalitysystem,oversighteffectivenessofprocessvalidation,cleaningvalidationandtransportationvalidationrelatedsitequalitysystems.
參與質(zhì)量體系的建立、執(zhí)行和維護(hù)，監(jiān)督工廠工藝驗(yàn)證，清潔驗(yàn)證及運(yùn)輸驗(yàn)證相關(guān)的質(zhì)量系統(tǒng)的有效性；
Providecompliancesupportwithcommentsduringprocessvalidation/confirmation,cleaningvalidation,transportationvalidationprotocolandreportpreparationandreview.
在工藝驗(yàn)證/確認(rèn)、清潔驗(yàn)證驗(yàn)證及運(yùn)輸驗(yàn)證方案及報(bào)告的準(zhǔn)備和審閱過程中提供合規(guī)指導(dǎo)；
Providecompliancesupportforinvestigation/deviationhandlingforprocessvalidation,cleaningvalidationandtransportationvalidationinvolvesomeprocessimprovementprojecthappenedinBNP.
為工藝驗(yàn)證、清潔驗(yàn)證和運(yùn)輸驗(yàn)證的調(diào)查及偏差處理提供合規(guī)支持，參與BNP工藝改進(jìn)項(xiàng)目。
DesirableRequirements:
LifeSciencebachelordegreeorabove.(Pharmacist,ChemistorequivalentscientificEducation),LocallanguageandEnglishfluentinspeaking/writing
生命科學(xué)本科以上相關(guān)學(xué)歷；（藥學(xué)、化學(xué)或相關(guān)科學(xué)專業(yè)教育），對于母語和英語具有流利的表達(dá)能力和較強(qiáng)的寫作能力
Min.5years’experienceofmanagementofproductionandquality,includingexperienceinin-processcontrolandqualitycontrol.
具有至少五年從事藥品生產(chǎn)和質(zhì)量管理的實(shí)踐經(jīng)驗(yàn)，包括從事過藥品生產(chǎn)過程控制和質(zhì)量檢驗(yàn)工作
WhyconsiderNovartis?
927million.That’showmanylivesourproductstouchedin2017.Andwhilewe’reproudofthatfact,inthisworldofdigitalandtechnologicaltransformation,wemustalsoaskourselvesthis:howcanwecontinuetoimproveandextendevenmorepeople’slives?
Webelievetheanswersarefoundwhencurious,courageousandcollaborativepeoplelikeyouarebroughttogetherinaninspiringenvironment.Whereyou’regivenopportunitiestoexplorethepowerofdigitalanddata.Whereyou’reempoweredtoriskfailurebytakingsmartrisks,andwhereyou’resurroundedbypeoplewhoshareyourdeterminationtotackletheworld’stoughestmedicalchallenges.
Joinusandhelpusreimaginemedicine.
